English to Spanish Medical Other Validation of the in vitro ELISA potency test

reproducibilidad??
no es mi área de especialización, por eso agradezco mucho los comentarios!

contexto:

RUGGEDNESS DESCRIPTION
Effect of ELISA Plate Lot Description
For the effect of plate lot, the effect of two (2) different plate lots were compared using ELISA conditions

For the study design, one (1) operator tested two (2) plate lots in three (3) sessions on different days, with both plate lots being tested on the same day, using a single vial preparation of master reference, assay control, and vaccines lot numbers xxx.
In each session there were two (2) plates tested each from a different lot.
The MR, assay control, and two vaccines were tested in two (2) replicate wells per dilution per plate lot using the plate layout listed in xx


Ruggedness assay conditions for Conjugate and Substrate are summarized in xx

Development work included testing of Final Product against the MR, ensuring that assay reagents are readily available, and determining final reagent concentrations.
Preliminary ruggedness testing of the ELISA was also done to test the effect of the ranges in incubation time and temperatures.


muchas gracias!!